A change of "consistency evaluation" in panoramic scanning

The hottest word in the pharmaceutical industry is the consistency evaluation of quality and efficacy of generic drugs (hereinafter referred to as consistency evaluation) However, for the market access and front-line sales personnel in the pharmaceutical industry, the consistency evaluation is relatively obscure The author uses two nights for three hours to sort out and analyze the overall situation of consistency evaluation for your reference (if there is any omission and objection, please leave a message for correction) 1、 Consistency evaluation related definitions consistency evaluation concept was first proposed in the rudiment (time) - to comprehensively improve the quality of generic drugs For the generic drugs approved before the implementation of the administrative measures for drug registration revised in 2007, the quality consistency evaluation shall be carried out with the generic drugs by stages and batches, among which the generic drugs included in the national basic drug catalog and commonly used clinical drugs shall be completed by 2015, those failing to pass the quality consistency evaluation shall not be registered again, and the drug approval certificate shall be cancelled According to the requirements of the measures for the administration of drug registration, drug manufacturing enterprises must conduct a comprehensive comparative study on the generic drugs they produce and the generic drugs they are imitated as the basis for application for re registration ——The State Council issued the 12th Five Year Plan for national drug safety on January 20, 2012, the source (time) of the concept of consistency evaluation officially put forward to improve drug approval standards Drugs are divided into new drugs and generic drugs Adjust the new drug from the current "drugs not listed and sold in China" to "drugs not listed and sold in China and abroad" According to the originality and novelty of material basis, new drugs are divided into innovative drugs and improved drugs Adjust generic drugs from "imitating drugs with existing national standards" to "imitating drugs with the same quality and efficacy as the original drugs" -- opinions of the State Council on reforming the review and approval system of medical devices (GF [2015] No.44) the original drugs It refers to the drugs that have been comprehensively studied in pharmacy, pharmacology and toxicology, and have complete and sufficient safety and effectiveness data as the basis for listing, have or have owned relevant patents, or have obtained patent authorization, and are first approved for listing abroad or in China In China, "original research drug" mainly refers to imported drugs that have passed the patent protection period The reference preparation was used as the reference drug for consistency evaluation, such as the original and internationally recognized drug of the same kind The reference preparation is a drug with reasonable prescription, stable quality and definite curative effect It mainly includes the original research drugs When the original research enterprise stops production, it can choose the drugs approved to be listed in the United States, Japan or the European Union and obtain the status of reference preparation 2、 A brief review of conformance evaluation policies in recent years 3 A brief process of conformance evaluation picture source: Network 4 Time limit for conformance evaluation 5 Relevant path of conformance evaluation At present, there are four ways to pass the consistency evaluation, which are "normal declaration", "priority approval", "deemed pass" and exemption from evaluation A simple example: normal declaration refers to carrying out drug research and human bioequivalence experiment in accordance with the policy requirements and following the procedures from beginning to end There are many relative paths for priority approval At present, the fastest path recognized in the industry is listed in the self inspection and verification project No 117 in 2015 The applicant voluntarily withdraws and re applies after the standards of consistency evaluation with the original research drug are improved Exemption from evaluation refers to the varieties declared and reviewed according to the principle of consistency with the quality and efficacy of the original investigational drug before listing according to the requirements of Document No 100 in 2017 The applicant shall assess whether they meet the requirements of the current technical guidelines for conformity evaluation If they meet the requirements after evaluation, the applicant can apply to the National Bureau for exemption from the conformity evaluation We are familiar with the situation of "co production", "one line, two certificates" and "one product, two sales", etc due to space, we will not give examples 6、 In some provinces, if the requirements for drug procurement based on consistency evaluation continue to develop, drug companies that originally expected to raise drug prices through consistency evaluation must be prepared for price reduction in order to obtain the market In the same way, this price reduction stimulation will also be transmitted to the original king of uncrowned - the original research drug In the era of the highest retail price, the original research drugs enjoy the preferential treatment of independent pricing, while the quality stratification of drug bidding and purchasing is high, and the low-level generic drugs kill each other Now, the original research drug has lost the Amulet of exclusive group, and the era of "high price and middle elevation cost open road" has been destroyed Under the constraint of "price reduction survival, price for quantity" mantra, the original research drug is helpless to be carried into the rolling price reduction trend, and the market sales structure will also change dramatically in the environment of quality improvement and price reduction, which is in line with the "low price, low rate" of sunshine ”The time has come 7、 The relevant impact of medical insurance payment standard will be remembered that at the end of 2015, a guiding opinion on the formulation rules of drug payment standard for basic medical insurance (Draft for comments) circulated in the industry almost clearly showed that the goal of establishing payment standard according to the common name in the future will remain unchanged, and a standard will be unified in the future After three years, according to the current comprehensive relevant policies, in the future, products with large price difference between the original research drug and the imitated drug will be given a transition period of 2-3 years to gradually realize the convergence of medical insurance payment price Thinking of this, I can't help thinking of the successful experience of a province The biggest possibility is that in three years' time, all the products of various dosage forms and specifications of the original generic drugs that have passed the consistency evaluation will be packaged into a group, the benchmark products will be selected as the representative of the standard dosage forms and specifications, and then the medical insurance payment standard of the benchmark products will be fixed, and the corresponding difference ratio will form their respective medical insurance payment prices The actual bid price and online price, ha ha, with the measurement of medical insurance payment standard, I'm afraid that the drug price will not fall?! National medical insurance payment standard for drug volume purchasing VIII Generic drugs replacing original research drugs On April 3, 2018, the State Council issued the opinions on reforming and improving the supply guarantee and use policy of generic drugs (GBF [2018] No 20) (hereinafter referred to as "No 20 document") "Article 9" stipulates that "the centralized purchasing agency of drugs shall prepare the purchasing catalogue according to the generic name of drugs, so as to promote the equal competition between generic drugs and original research drugs consistent with the quality and efficacy of the original research drugs" According to sun Zhongxin, an expert in the national monitoring system for rational drug use of the former Ministry of health, in the recently published medical economic newspaper, even though the drugs that pass the consistency evaluation cannot be completely consistent in the processes of digestion, absorption, metabolism and excretion due to the differences in raw materials, chemical structure, excipients and processes, so in terms of clinical efficacy and safety, There may also be differences between the original drug and the drug passing the consistency evaluation For the price reduction of the original research drug, the famous industry expert Lao Badou wrote that "if the imitated product can not launch a real challenge to the original research drug in terms of quality, efficacy and related services, then the price challenge will never succeed" Consistency evaluation is a necessary choice to keep the market, but related pharmaceutical companies should take a long-term view From the perspective of national policy, the consistency evaluation will greatly improve the level of China's generic drugs, "try our best to solve the situation that China's generic drug industry is large but not strong and" how small and scattered is poor " However, the fundamental intention is to grasp both the research and development of generic drugs and the creation of new drugs From this point of view, ironmaking needs to be more hard Only passing the consistency evaluation can we get a passing score To win the favor of the market, we must have the determination and confidence of half of the people who have traveled for hundreds of miles, consolidate our own foundation, and then we can easily climb over obstacles and win the future I hope that "take less medicine, but take better" will become a reality as soon as possible.